Apparatus, system and method for a dissolvable valve member

ABSTRACT

A valve assembly is provided which includes a housing having an inlet end and an outlet end and defining a fluid channel and a central chamber. A dissolvable valve member is positioned to obstruct flow through the channel within the chamber. The dissolvable valve member is formed of a material which is dissolvable at a predetermined rate upon contact with a preselected fluid. The preselected fluid is selected from the group consisting of blood, urine, saline and antimicrobial solutions. The dissolvable valve member can be formed from a fluid soluble glass or a starch based material.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of and claims the benefitof priority under 35 U.S.C. §120 to co-pending U.S. patent applicationSer. No. 12/485,205, filed Jun. 16, 2009, entitled Valve AssemblyIncluding a Dissolvable Valve Member, which claims priority under 35U.S.C. §119(e) to U.S. provisional application Ser. No. 61/076,850,filed Jun. 30, 2008. Each of the preceding applications is hereinincorporated by reference in its entirety.

BACKGROUND

1. Technical Field

The present disclosure relates to medical apparatus including a valveassembly having a dissolvable valve member and, more particularly, to arelief valve assembly having a dissolvable valve member for use with aurinary catheter.

2. Background of Related Art

Urinary catheters for draining fluid from a patient's bladder are wellknown in the art. Typically, urinary catheters include a flexible bodywhich is dimensioned to be inserted through the urethra into thebladder. The distal end of the catheter includes an expandable bulb orballoon which can be expanded within the bladder, via a gas inlet valveand conduit, to retain the distal end of the catheter within thebladder. The flexible body further defines a drain lumen which allowsfluid to drain from the bladder into a urine collection bag. The urinarycatheter also includes a sampling port and an irrigation lumen whichallows an irrigation fluid to be injected through the catheter into thebladder to irrigate the bladder. In addition to facilitating withdrawalof urine from the catheter for testing, the sampling port can also beused to inject an anti-microbial solution into the catheter to reducethe risk of infection to the patient.

When an irrigation fluid and/or an anti-microbial solution is injectedinto a catheter, medical personnel must clamp the catheter downstream ofthe injection site for a specified period of time to prevent theirrigation fluid and/or anti-microbial solution from immediatelydraining from the bladder and/or catheter. If the medical personnel failto remove the clamp, fluid will back up in the bladder and result indiscomfort and potential serious harm to the patient.

Accordingly, a continuing need exists in the medical arts for a deviceusable with a catheter which can retain an irrigation solution and/oranti-microbial solution within a catheter for a specified period of timeand, thereafter, permit drainage of the catheter without intervention bymedical personnel.

SUMMARY

A valve assembly is provided which includes a housing having an inletend and an outlet end and defining a fluid channel and a centralchamber. A dissolvable valve member is positioned to obstruct flowthrough the channel within the chamber. The dissolvable valve member isformed of a material which is dissolvable at a predetermined rate uponcontact with a preselected fluid. The preselected fluid is selected fromthe group consisting of blood, urine, saline and antimicrobialsolutions. The dissolvable valve member can be formed from a fluidsoluble glass or a starch based material. Alternatively, the use ofother dissolvable materials is envisioned. The housing can include aninlet housing portion and an outlet housing portion which are configuredto be secured together to define the central chamber. The inlet end ofthe housing is adapted to releaseably engage a drain lumen of a medicaldevice, e.g., urinary catheter. The outlet end of the housing is adaptedto releasably engage a fluid conduit of a urine collection system. Inone embodiment, the housing has at least one vent configured to vent airfrom within the valve assembly. The at least one vent can include aninlet vent and an outlet vent.

In one embodiment, the dissolvable valve member is formed from a thindissolvable material. In another embodiment, the dissolvable valvemember includes a substantially cylindrical body having an inlet sideand an outlet side. At least one of the inlet side and the outlet sidecan define a spherical concavity. Alternatively, the cylindrical bodycan have substantially rectangular cross-section. In one embodiment, thecylindrical body defines a stepped cross-section, wherein a centralportion of the body has a smaller width than an outer portion of thebody. The body can define one or more throughbores.

A urinary catheter assembly is also provided which includes a catheterhaving a body defining a central drain lumen for positioning within abladder of a patient having an outlet end defining a drain lumen outlet.A valve assembly includes a housing adapted to releasably engage theoutlet end of the body of the catheter. The housing defines a fluidchannel and a chamber. The valve assembly further includes a dissolvablevalve member positioned to obstruct flow through the channel. Thedissolvable valve member can be formed of a material which isdissolvable at a predetermined rate upon contact with a preselectedfluid. The preselected fluid can be selected from the group consistingof blood, urine, saline and antimicrobial solutions. The dissolvablevalve member can be formed from a fluid soluble glass or a starch basedmaterial. The housing can have at least one vent configured to vent airfrom within the valve assembly. Alternatively, the dissolvable valvemember can be formed from a thin dissolvable material.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed valve assembly includinga dissolvable valve member are disclosed herein with reference to thedrawings, wherein:

FIG. 1 is a side perspective view of one embodiment of the presentlydisclosed valve assembly;

FIG. 2 is a side view of the valve assembly shown in FIG. 1 attached toa urinary catheter assembly;

FIG. 3 is a side partial cross-sectional view of the valve assembly andurinary catheter assembly shown in FIG. 2 with a syringe assemblyfastened to the urinary catheter assembly;

FIG. 4 is an enlarged view of the indicated area of detail shown in FIG.3;

FIG. 5 is a top perspective view of one embodiment of the dissolvablevalve member of the presently disclosed valve assembly shown in FIG. 1;

FIG. 6 is a side cross-sectional view of the dissolvable valve membershown in FIG. 5;

FIG. 7 is a top perspective view of another embodiment of thedissolvable valve member of the presently disclosed dissolvable fluidrelief valve assembly shown in FIG. 1;

FIG. 8 is a side cross-sectional view of the dissolvable valve membershown in FIG. 7;

FIG. 9 is a top perspective view of another embodiment of thedissolvable valve member of the presently disclosed dissolvable fluidrelief valve assembly shown in FIG. 1;

FIG. 10 is a side cross-sectional view of the dissolvable valve membershown in FIG. 9;

FIG. 11 is a top perspective view of another embodiment of thedissolvable valve member of the presently disclosed dissolvable fluidrelief valve assembly shown in FIG. 1;

FIG. 12 is a side cross-sectional view of the dissolvable valve membershown in FIG. 11;

FIG. 13 is a top view of an alternative embodiment of the presentlydisclosed valve assembly including a dissolvable valve member, and

FIG. 14 is a side partial cross-sectional view of the valve assemblyshown in FIG. 13.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed valve assembly including adissolvable valve member will now be described in detail with referenceto the drawings wherein like reference numerals designate identical orcorresponding elements in each of the several views.

FIGS. 1-4 illustrate one embodiment of the presently disclosed valveassembly shown generally as 10. Valve assembly 10 includes a housing 11which includes an inlet housing portion 12, and an outlet housingportion 14, and a dissolvable valve member 16 (FIG. 4). Inlet housingportion 12 is substantially tubular and defines a fluid channel 18 (FIG.3). Inlet housing portion 12 includes an outlet end 22 and an inlet end20. Inlet end 20 defines an inlet bore 24 which converges towards outletend 22 and is dimensioned to releasably receive an outlet end 50 a of aurinary catheter 50. Outlet end 22 of housing portion 12 defines anouter stepped portion 26 (FIG. 4) and an inner annular extension 28.Annular extension 28 defines a cylindrical chamber 34 (FIG. 4).

Outlet housing portion 14 defines a fluid channel 18 a which is in fluidcommunication with fluid channel 18 of inlet housing portion 12. Aninlet end 30 of outlet housing portion 14 has an inner stepped portion32 which is dimensioned to receive annular extension 28 of inlet housingportion 12. Inner stepped portion 32 has a width which is greater thanthe width of annular extension 28 such that inner stepped portion 32defines a shoulder 32 a. Shoulder 32 a and annular extension 28 togetherdefine cylindrical chamber 34. Chamber 34 is dimensioned to receivedissolvable valve member 16 as will be discussed in further detailbelow. Outlet end 22 of housing portion 12 is secured to inlet end 30 ofoutlet housing portion 14 such as by sonic welding, adhesives, screwthreads, or the like, such that dissolvable valve member 16 is retainedin chamber 34.

Inlet and outlet housing portions 12 and 14 can be formed from a clearor transparent material, e.g., transparent polymeric materials includingpolycarbonates. One such material which is commercially available isLEXAN®. A transparent material allows medical personnel to visuallyconfirm that the valve assembly 10 is functioning properly, i.e., thatthe valve member 16 has dissolved in the specified period of time andthat fluid is flowing through the valve assembly 10. It is envisionedthat the valve member can include a contrasting color to improvevisualization of the valve member.

Each of inlet and outlet housing portions 12 and 14 also includes avent. More specifically, an upper vent 38 is supported on inlet housingportion 12 and a lower vent 40 is supported on housing portion 14. Vents38 and 40 allow air from within catheter 50 and valve assembly 10 to beremoved from fluid channels 18 and 18 a. An outlet end 42 of housingportion 14 includes a thin walled extension 42 a (FIG. 4) which isdimensioned to frictionally engage a collection tube (not shown) of aurine collection system (not shown).

FIGS. 5 and 6 illustrate one embodiment of the presently discloseddissolvable valve member 16. Valve member 16 has a body 60 having aninlet side 62 and an outlet side 64. Each side includes an inwardlystepped configuration. More specifically, inlet side 62 includes aseries of annular steps 62 a, 62 b and 62 c and central blind bore 62 dand outlet side 64 includes a series of annular steps 64 a, 64 b, 64 cand a central blind bore 64 d. The steps are configured such that thewidth of body 60 decreases towards a central axis of body 60. In oneembodiment, valve body 60 is formed from a dissolvable material such aswater soluble glass. Alternatively, other dissolvable materials ofconstruction can be used to construct valve member 16 including starchbased materials. The thickness and configuration of body 60 and theparticular material of construction should be selected to provide thedesired rate at which the valve member 16 dissolves.

Referring now to FIGS. 2 and 3, valve assembly 10 is particularly suitedfor use with a urinary catheter 50. Urinary catheter 50 includes anelongated flexible body 70 which is shown cutaway in FIGS. 2 and 3. Adistal end (not shown) of body 70 is dimensioned to be inserted throughthe urethra and into the bladder. The distal end of body 70 includes anexpandable member or balloon (not shown) for retaining the distal end ofbody 70 within the bladder.

Catheter assembly 50 includes a body defining a central drain lumen 72(FIG. 3), a valved sampling port 74, a balloon supply port 76 and anirrigation lumen 78. Balloon supply port 76 provides an access port forsupplying pressurized gas to the balloon (not shown). Irrigation lumen78 communicates with a distal end (not shown) of body 70 to supplyirrigation fluid to the bladder (not shown). Sampling port 74 includes avalved port which includes a connector 80 (FIG. 2) for releasablyengaging a syringe fitting of a syringe assembly 82 (FIG. 3). Syringeassembly 82 can be used to inject fluid into or withdraw fluid fromcentral drain lumen 72 of catheter assembly 50.

When inlet end 20 of inlet housing portion 12 of valve assembly 10 isreleasably coupled with catheter assembly 50 and a distal end ofcatheter assembly 50 is inserted into a patient's bladder, an irrigationsolution can be injected into the bladder by injecting the solution,e.g., saline, through the irrigation lumen 78 into the bladder. Ananti-microbial solution, e.g., ethylene diamine tetracetic acid(“EDTA”), can also be injected through supply port 76 into central drainlumen 72 of catheter assembly 50 to flush or lock the catheter. When anirrigation fluid and/or anti-microbial solution is injected intocatheter assembly 50, the fluid will flow into central drain lumen 72and enter channel 18 of inlet housing portion 12 of valve assembly 10.The dissolvable valve member 16 of valve assembly 10 is positionedbetween channel 18 of inlet housing portion 12 and channel 18 a ofoutlet housing portion 14 to prevent or obstruct fluid from exitingdrain lumen 72 until a predetermined period of time has elapsed. Thedissolvable valve member 16 of valve assembly 10 allows medicalpersonnel to lock and flush catheter assembly 50 without the need of amechanical clamping device to ensure that drainage is reestablishedwithout medical personnel intervention.

As discussed above, valve member 16 can be constructed from fluidsoluble glass or, alternatively, from starch based materials, which canbe designed to dissolve over time after exposure to blood, urine, salineor antimicrobial solutions such as EDTA. The soluble glass used maycomprise phosphorus pent oxide as the principle glass forms togetherwith any one or more glass-modifying non-toxic materials such as sodiumoxide, potassium oxide, magnesium oxide and calcium oxide.Alternatively, other dissolvable materials may be used to form the valvemember. Further, the dissolvable material, e.g., glass can beimpregnated with a drug or anti-microbial which is released into thecatheter or other medical device as the valve member dissolves. Thematerials noted above can be engineered to dissolve over specific timeperiods such as seconds, minutes and hours. Combinations of fluidtemperature, valve surface area, geometry and material dissolution ratefor both soluble glass and starch based material valve members allow foran infinite number of time ranges to be established in which the valvemember would dissolve and fluid flow from the catheter would bereestablished.

FIGS. 7-12 illustrate alternative embodiments of the dissolvable valvemember 16. In FIGS. 7 and 8, valve member 116 has a substantiallycylindrical body 118 which includes an inlet side 162 defining asubstantially spherical concavity 162 a and an outlet side 164 defininga substantially spherical concavity 164 a. Concavities 162 a and 164 aare separated by a barrier 166. In FIGS. 9 and 10, valve member 216includes a substantially cylindrical body 218 having a recessed inletside 262, a recessed outlet side 264 and a barrier member 266 having arectangular cross-section. In FIGS. 11 and 12, valve member 316 includesa substantially cylindrical body 318 having a recessed inlet side 362, arecessed outlet side 364 and a barrier member 366 having a rectangularcross-section and a plurality of through bores 368. Valve member 316provides for a reduced flow rate through bores 368 of valve member 316.As the valve member 316 dissolves, the flow rate across the valve memberwill increase.

It is envisioned that a variety of valve member configurations can beused to achieve the advantages described. Only a few representativeembodiments have been described herein. For example, the valve memberneed not be cylindrical but rather may assume a variety of differentconfigurations, e.g., square, triangular, rectangular, etc.

FIGS. 13 and 14 illustrate an alternative embodiment of the presentlydisclosed valve assembly shown generally as 400. Valve assembly 400includes an inlet housing portion 412, an outlet housing portion 414 anda valve member 416. Inlet housing portion 412 includes a vent 438 andoutlet housing portion includes a vent 440. Inlet housing portion 412includes an inlet conduit 420 which is adapted to be releasablyconnected to the drain tube of a catheter (not shown). Outlet housingportion 414 includes an outlet conduit 422 which is adapted to bereleasably connected to a urine collection device. Inlet and outlethousing portions 412 and 414 define a valve chamber 430 which is dividedby valve member 416. In one embodiment, valve member 416 is formed of athin film starch based dissolvable material. Alternatively, other knowndissolvable materials may be used.

In use, valve assembly 400 functions in a manner similar to valveassembly 10 as described above. More specifically, when a fluid, e.g.,urine, blood, EDTA, etc., flows through inlet conduit 420 into valvechamber 430, the fluid engages valve member 416 causing valve member 416to dissolve at a specified rate. When valve member 416 dissolves, fluidis able to flow through valve member 416 through outlet conduit 422.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, the valve assembly and/orvalve member may assume a variety of configurations not shown herein,e.g., rectangular, square, oval, etc. Further, the valve assembly can beused in association with medical devices other than urinary catheters,including, for example, blood collection devices, IV administrationsets, and abdominal drainage tubes. It is also envisioned that one ormore dissolvable valve members can be used together. For example, three“five minute” dissolvable valve members may be used together to allowmedical personnel to assess more easily the time remaining tore-establish flow. Therefore, the above description should not beconstrued as limiting, but merely as exemplifications of embodiments.Those skilled in the art will envision other modifications within thescope and spirit of the claims appended hereto.

What is claimed is:
 1. A valve assembly configured to employ with aurinary catheter, the valve assembly comprising: a housing having aninlet end and an outlet end and defining a fluid channel and a centralchamber, the inlet end dimensioned to releasably receive an outlet endof the urinary catheter; and a dissolvable valve member positioned toprevent flow through the channel in its undissolved state, thedissolvable valve member being formed of a material and being configuredwith dimensions and in a shape to dissolve and automatically open theflow through the channel following a pre-determined time-period duringwhich the dissolvable valve member is in contact with a preselectedfluid.
 2. The valve assembly of claim 1, wherein the dissolvable valvemember includes an inlet side, an outlet side, a central axis and aregion proximate the central axis, and wherein the region proximate thecentral axis is a location of a minimum thickness of the dissolvablevalve member between the inlet side and the outlet side.
 3. The valveassembly of claim 2, wherein at least one of the inlet side and theoutlet side define a concavity.
 4. The valve assembly of claim 3,wherein each of the inlet side and the outlet side define a sphericalconcavity.
 5. The valve assembly of claim 2, wherein the dissolvablevalve member is constructed such that a thickness of the dissolvablevalve member increases in a series of steps from the minimum thicknessto a maximum thickness located about a periphery of the dissolvablevalve member.
 6. The valve assembly of claim 2, wherein the minimumthickness is selected to provide the flow through the channel followingthe pre-determined time-period.
 7. The valve assembly of claim 6,wherein the preselected fluid is selected from a group consisting ofurine and blood.
 8. The valve assembly of claim 2, wherein the materialis impregnated with an anti-microbial agent that is released into theurinary catheter as the material dissolves.
 9. The valve assembly ofclaim 1, wherein the material is impregnated with a drug that isreleased into the urinary catheter as the material dissolves.
 10. Thevalve assembly of claim 1, wherein the material is selected from a groupconsisting of a fluid soluble glass and a starch based material.
 11. Amethod of temporarily blocking a flow of fluid in a urinary catheter,the method comprising: locating a dissolvable valve member to block theflow of fluid in the urinary catheter; and selecting the dissolvablevalve member with a geometry and a material of construction such that adissolution of the valve member automatically occurs following apre-determined time-period during which the dissolvable valve member isin contact with a preselected fluid, the dissolution permitting the flowof fluid.
 12. The method of claim 11, further comprising varying athickness of the dissolvable valve member between a region having aminimum thickness located in a radially central portion of thedissolvable valve member and a region having a maximum thickness locatedin a peripheral portion of the dissolvable valve member.
 13. The methodof claim 12, further comprising selecting the minimum thickness to allowthe flow through the urinary catheter following the pre-determinedtime-period.
 14. The method of claim 13, wherein the dissolvable valvemember includes an inlet side and an outlet side, and wherein the methodfurther comprises including a concavity in a shape of at least one ofthe inlet side and the outlet side.
 15. The method of claim 14, furthercomprising including the concavity in the shape of each of the inletside and the outlet side.
 16. The method of claim 12, further comprisingincluding at least one step-change in thickness in at least one of theinlet side and the outlet side.
 17. The method of claim 11, furthercomprising impregnating the material of construction with a drug forrelease into the urinary catheter as the material dissolves.
 18. Themethod of claim 11, further comprising impregnating the material ofconstruction with an anti-microbial agent for release into the urinarycatheter as the material dissolves.
 19. The method of claim 11, furthercomprising selecting the material of construction from a groupconsisting of a fluid soluble glass and a starch based material.